The IBA’s response to the war in Ukraine
The essential role of evolving technologies in securing a safe and sustainable food supply
Lynn L Bergeson
Bergeson & Campbell PC, Washington
Emerging tools enabled by nanotechnology, synthetic biology, and other innovative technologies are today increasingly supplementing the ploughs and tractors so emblematic of the agricultural community of the past. These precision farming tools are ensuring a sustainable food supply otherwise threatened by climate change and population growth, among other global challenges, while diminishing worldwide greenhouse gas emissions. Genetically modified E coli is being used to produce synthetically-derived pheromones, substances beneficially used in agricultural applications to attract, capture, and eliminate harmful pests. Agricultural stakeholders use nanopesticides and nanofertilisers in drought-stricken regions, minimising the need for more conventional and environmentally consequential agricultural chemicals. GPS-based auto-steering systems for tractors augment human labour, freeing up effort better spent on other tasks. These technologies enable global agricultural professionals to address the climate change imperatives which threaten an increasingly fragile global food supply.
Emerging technologies do not come without potential risks, however, and how best to regulate them is a subject on which stakeholders do not always agree. This article considers several emerging agricultural technologies and briefly outlines US governance systems and their ability to keep pace effectively with technological innovation. While the US governance system is capable of effectively addressing potential risks posed by evolving technologies, agricultural stakeholders need to ensure that policy makers and regulators are aware of these technologies and the benefits they offer in providing a secure and sustainable food supply.
Government and private-sector nanotechnology commercialisation efforts have resulted in a growing number of products entering the market. Nano-agrochemicals, nanopesticides, and nanofertilisers are products of growing interest, given their demonstrated ability to deliver improved results. Relevant applications include the use of nano- and microemulsions, nano- and microencapsulations, nanoparticle-based fertilisers, and the use of nanomaterials to improve photocatalytic efficiency. Nanotechnology-based biosensors reflect the utility of these technologies. They assist farmers in targeting areas for crop optimisation and work in atypical environments such as in saline water, an especially useful feature to aquafarmers. Ongoing research is devoted to realising the potential of nanotechnology to improve nutrition. Nanocapsules in medicine, for example, release nutrients targeted at certain areas of the body at optimal times of the day.
Sometimes referred to as ‘extreme genetic engineering’, synthetic biology applies the same fundamental principles of traditional recombinant DNA, but at a much greater scope and speed using biological tools and methods. Gene editing, including CRISPR technology, has many applications in agriculture, including editing techniques that improve a crop’s resistance to weather fluctuations and diseases. Another synthetic biology technology uses genetically modified E coli to produce pheromones to aid in pest mitigation by attracting, capturing, and eliminating pests without the use of harmful chemicals or other pollution-causing agents. Other technologies under development include tools using engineered yeast and fermentation techniques that produce foods, including animal-free milk products, and certain flavourings. Other technologies use engineered microalgae to produce algal butter and vegan proteins.
Synthetic biology applications are increasingly being used to modify ornamental plants. These plants are valued for their flowers, leaves, scents, textures, fruit, stems, and bark. They have been bred to accentuate desirable traits and minimise undesirable ones through traditional cross-breeding, grafting, and other techniques. For example, scientists at BioGlow LLC (BioGlow) have inserted genes from luminous marine bacteria into Nicotiana alata (jasmine tobacco), a common flowering ornamental plant, producing a plant that is autoluminescent, meaning it glows in the dark with only standard plant nutrients. Glowing Plant, Inc (Glowing Plant) has also developed a luminescent plant. Building on technology similar to BioGlow’s, Glowing Plant inserted genetic material into Arabidopsis thaliana (thale cress) using a ‘gene gun’. Genes from Photinus pyralis (common eastern firefly) and two synthetic variants of genes from Aequorea victoria (crystal jelly) are inserted into the plant’s genome. While these are not food applications, the technologies are expected to have broader agricultural application.
While the use of genetically modified organisms (GMOs) is not a new technology to the agricultural sector, the modern use of genetic engineering to recombine DNA in different organisms to the precise degree and speed that transpires today is what differentiates traditional biotechnology from more contemporary agricultural biotechnology. The availability of insect-resistant crops capable of expressing Bacillus thuringiensis (Bt) protein has greatly increased corn, potato, and cotton crop yields. Genetic engineering and enzyme optimisation are tools used to produce biofuels, resulting in energy-dense and high-yield crops. Pesticide-resistant crops save farmers time and money. The list of biotech innovations is long, and the implications are significant.
Oversight of agriculture in the United States
Domestic farm bills in the United States chiefly govern agriculture at the federal level. The most recent farm bill was enacted in December 2018 and expires in 2023. It covers a range of topics, including conservation, commodities, farm credit, and rural development. Governance is both a federal and a state and local responsibility. The US Department of Agriculture (USDA) is the federal agency responsible for the farm bill’s implementation.
Other federal laws and state programmes regulate specific aspects of agriculture. The Plant Protection Act (PPA), for example, regulates the movement of plants and treatment of plant pests, noxious weeds, and related organisms. Genetically modified crops are subject to the jurisdiction of multiple federal agencies under the Coordinated Framework for Regulation of Biotechnology. Issued in 1986, the Coordinated Framework lays down an organisational blueprint for federal agencies and establishes lead responsibilities for the federal oversight of products of biotechnology. The core premise of the Coordinated Framework is that the legal authorities that existed in 1986 – authorities that remain largely unchanged today – provide federal regulators with sufficient oversight authority to address any potential health or environmental risk that a biotechnology product might pose.
Three federal agencies are principally responsible for regulating products of biotechnology under the Coordinated Framework. These are: USDA – in particular the Animal and Plant Health Inspection Service (APHIS) – the US Environmental Protection Agency (EPA), and the US Food and Drug Administration (FDA). APHIS is responsible for regulating field trials of genetically modified crops and plants under the PPA. The EPA regulates genetically engineered microbes under the Toxic Substances Control Act (TSCA) and genetically engineered pesticides and pesticides incorporated into plants under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The FDA regulates a broad spectrum of products, including human and animal drugs, cosmetics, dietary supplements, food, food additives, and medical devices, among others, under the Federal Food, Drug, and Cosmetic Act (FFDCA). How each agency regulates biotechnology products, pursuant to what legal authority, and when in the commercialisation process regulatory oversight attaches vary considerably.
Pesticides are a critically important part of agriculture. In the US, the EPA regulates pesticides under FIFRA and provisions of the FFDCA, as amended in 1996 by the Food Quality Protection Act (FQPA). The FIFRA broadly defines a pesticide as ‘any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest’. To approve a pesticide registration, the EPA must conclude that the pesticide performs its intended function without causing unreasonable adverse effects on the environment. The EPA’s risk assessment of a pesticide is based on robust and complete data. Because there may be, and usually are, gaps in the database for a pesticide, EPA risk assessors often estimate values and use professional judgement when performing risk calculations. New data and other information and revised assessment techniques may support refined risk assessment. The FIFRA authorises the EPA to obtain any additional data deemed necessary to maintain ‘in effect an existing registration’.
Pursuant to FFDCA Section 408(b)(2)(A), the standard for establishing a tolerance (the amount of pesticide residue that may lawfully remain on food) is whether there is a ‘reasonable certainty that no harm’ will result from exposure to the pesticide, including all dietary and other exposures. FIFRA registrants must obtain pre-market approval before commercialising their products, a process that can take years and requires significant data to support the safety finding that the EPA must make under the FIFRA.
US governance approach to evolving technologies
How the US regulates food and feed products derivative of evolving technologies is a function of the specific use at issue, the application of the legal authorities summarised above, and other constantly evolving policy considerations. The US governance approach is based on principles of risk assessment, risk management, and risk communication. It recognises the economic value of the agricultural sector, the absolute need for food safety, and the value of broad stakeholder engagement at the national, state, and local levels. The approach requires substantial scientific data generated by manufacturers to form the basis of the risk management decisions made by the respective regulatory officials.
With regard to nanomaterials used in food and feed applications, the US approach is based on traditional principles of risk assessment that consider the physical-chemical properties of specific nanoscale substances and materials. The EPA reviews product applications on a case-by-case basis, and no inferences adverse to the review are based on size considerations alone. The EPA’s specific FIFRA policies on nanomaterials, as well as its adoption of risk assessment policies and approaches, have been evolving over the years. Under the FIFRA, the EPA has conditionally approved two nanosilver pesticide registrations, each considered a new ‘active ingredient’ and subjected to the most stringent review under the FIFRA. On 1 December 2011, the EPA announced the conditional registration of HeiQ AGS-20, a nanosilver-based antimicrobial pesticide product approved for use as a preservative for textiles. On 19 May 2015, it announced a second conditional registration for a nanosilver-containing antimicrobial pesticide. While the EPA is ready to embrace nanopesticides, other stakeholders have expressed a different view. Detractors of these pesticide products sued the EPA, but both are in commercial use despite these judicial challenges.
Areas for oversight improvement
In the US, federal oversight of agricultural technologies is comprehensive, complicated, and constantly evolving. The system is based on rigorous scientific analyses, and the considerations for product approval are comprehensive and robust. The US government is openly supportive of technologies and their applications in the agricultural sector as a matter of national policy, and it views US competitiveness with other countries as enhanced by fostering a ‘can-do’ attitude. The US approach to managing potential risks is rooted in laws regulating ‘products’, and not the technologies which produce them. The federal agencies charged with implementing these laws – EPA, USDA, and FDA – have for years been actively engaged in reviewing, adapting, and modernising the authorities available to them; their regulatory actions are properly calibrated to identify and manage, as appropriate, any potential risk that the products of these technologies may pose.
There is need for improvement. Employing governance approaches more solicitous of public engagement and more cognisant of the values that risk-benefit decisions necessarily involve would improve our governance approach. Managing risk is about achieving one prudent outcome that is preferred over others. To make informed decisions, governance approaches must ensure that the public is sufficiently informed to make good choices early enough in the administrative process to make a difference.
A second point that could make the US oversight system more coherent is a clearer conceptual framework for quantifying ‘benefits’. Our core ‘product’ approval statutes, TSCA and FIFRA, are risk-benefit laws. The public and decision makers hear a great deal about potential risks from evolving technologies. Decision makers, however, hear too little about the benefits derivative of these technologies. Stakeholders tend to communicate benefits in ways that make it difficult to understand outside of a narrow regulatory context, as ‘benefits’ are often defined in stilted, cost-benefit jargon devoid of the value of emerging technologies as a beneficial, socially disruptive agent.
A third point relates to the continuing challenge of ensuring technological literacy within the ranks of decision makers and public. As technological innovations, especially those that affect the food supply, become increasingly sophisticated, the demands placed on decision makers and their staff are increasingly onerous. There is an urgent need for literacy and a reliable, credible, and systematic source of balanced information.
The private sector could improve its efforts to educate the public, regulators, and lawmakers about innovations. It should cultivate and maintain a high level of technological literacy, taking advantage of all forms of media. This could be achieved through public-private partnerships, enhanced funding to independent think tanks, or other means.
Ensuring a reliable, safe, and sustainable global food supply is essential. Today’s agricultural professionals are increasingly dependent on evolving technologies to maximise crop yields, enhance vector control, optimise the utility of dwindling land capacity, and cut greenhouse gases. US governance systems ensure emerging technologies are safe; we need more to provide lawmakers, regulators, and the public with credible and current information about their risks and benefits. Given the financial constraints facing federal and state governments, the burden falls on the private sector to intensify efforts to educate stakeholders about the value of emerging technologies and their essential role in feeding the world.